# Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial 2/3

> **NIH NIH R01** · UNIVERSITY OF COLORADO DENVER · 2023 · $266,682

## Abstract

Abstract
Infertility is a common complication of endometriosis; while IVF successfully treats endometriosis-associated
infertility, pregnancy rates are diminished compared to other etiologies of infertility. Our long- term objectives are
to better identify and treat endometriosis related infertility. Our central hypothesis is that in infertile woman with
endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those
pretreated with GnRH antagonist compared to placebo. The use of gonadotropin releasing hormone (GnRH)
agonist prior to IVF has been suggested to improve success, however studies have been small and rarely
reported live birth rates. Further, use of this approach is limited by the long treatment time required. Recent
approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis
who are undergoing IVF. This agent avoids parenteral administration and the prolonged delay in initiation of
action as was seen with GnRH agonists. There have been no studies on the efficacy of GnRH antagonists for
the treatment of endometriosis-related infertility. We propose a randomized clinical trial of oral GnRH
antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome
of live birth rate. We have also recently demonstrated aberrant microRNAs in the circulation of women with
endometriosis, a panel of which we have subsequently validated as a biomarker with high sensitivity and
specificity for the detection of active disease. We secondarily propose that disease biomarkers will identify
women who will benefit from GnRH antagonist pre-treatment, allowing a precision medicine approach to
endometriosis-related infertility. The proposed study is significant due to the common occurrence of both infertility
and endometrioses as well as the lack of precision in both diagnosis and therapy. We use an innovative approach
to identify endometriosis as well as a novel intervention designed to improve the prognosis of women with
endometriosis undergoing IVF.

## Key facts

- **NIH application ID:** 10696953
- **Project number:** 5R01HD100343-05
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Nanette F. Santoro
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $266,682
- **Award type:** 5
- **Project period:** 2019-09-26 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10696953

## Citation

> US National Institutes of Health, RePORTER application 10696953, Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial 2/3 (5R01HD100343-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10696953. Licensed CC0.

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